Treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.

Treatment of locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.

Treatment of metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy.

For treamtent of adult and pediatric patients with unresectable or metastatic, mircosatellite instability-high (MSI-H) or mismatch repair deficient solid tumors or colorectal cancer that have progressed following prior treatment.

For treatment of patients with hepatocellular cancer (HCC) who have been previously treated with sorafenib.

Note: if a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How This Drug Is Given:

Nivolumab is administered intraveniously (IV) into the vein over 60 minutes every 2 weeks.

The amount of nivolumab that you will receiv depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Higher doses do not give a better response and may cause increased toxicity. Your doctor will determine your dose and schedule.

If you miss any appointments call your healthcare provider as soon as possible to reschedule your appointment.

Side Effects:

Things to remember about the side effects of nivolumab:

Most people do not experience all of the side effects listed.

Side effects are often predictable in terms of their onset and duration.

Side effects are almost always reversible and will go away after treatment is complete.

There are many options to help minimize or prevent side effects.

There is no relationship between the presence or severity or side effects and the effectiveness of the medications

The following side effects are common (occurring in greater than 30%) for patients taking nivolumab:

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

A few rare but severe side effects include:

Immune-mediated Pneumonitis

Immune-mediated Colitis

Immune-mediated Hepatitis

Immune-mediated Nephritis and Renal Dysfunction

Immune-mediated Hypothyroidism and Hyperthyroidism

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

Fever of 100.4° F (38° C) or higher, chills

Signs of an allergic reaction, like rash; hives; itching; red, peeling, or blistered skin with or without fever; tightness in the chest or throat; wheezing; trouble breathing or talking; unusual hoarseness; or swlling of the lips, mouth, face, throat, or tongue.

Precautions:

Before starting nivolumab treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).

Do not receive any kind of immunization or vaccination without your doctor's approval while taking nivolumab.

Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (nivolumab may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).

For both men and women: Do not conceive a child (get pregnant) while taking nivolumab. Barrier methods of contraception, such as condoms, are recommended while you are taking this drug and for 5 months after you stop taking it. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.

Do not breast feed while taking this medication.

Self-Care Tips:

Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.

Nivolumab can cause visual changes, dizziness and tiredness. If you have any of these symptoms, use caution when driving a car, using machinery, or anything that requires you to be alert.

In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.

Get plenty of rest.

Maintain good nutrition. (see eating well during chemotherapy)

If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking nivolumab to monitor side effects and check your response to therapy.

How This Drug Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the difference between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific difference in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of teh cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenisis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 and itÃ¢â‚¬â„¢s logands, PD-L1 and PD-L2. Binding these ligands to the PD-1 receptor found on T cells, inhibits T cell proliferation and cytokine production. Upregulation of the PD-1 ligands occurs in some tumors and signaling through this pathway can contribute to inhibition of active T-cell immune surveillance of tumors. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, resulting in decreased tumor growth.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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